Quality Specialist

Job Title:

Quality Specialist Job Description The Quality Specialist supports remediation activities with a primary focus on retrospective complaint review and medical device reportability assessments in alignment with FDA requirements. This role reviews both historical and newly received product complaints to determine MDR reportability under 21 CFR Part 803, ensuring accurate documentation and compliance within strict remediation timelines. Responsibilities Review historical complaint files as part of remediation or retrospective review efforts to verify completeness and reassess MDR reportability decisions. Apply current FDA MDR definitions, criteria, and decision trees to legacy and new complaints to determine whether an MDR should have been filed or should be filed. Identify missing or incomplete data within complaint records and work cross-functionally with Quality, Regulatory, Operations, and other stakeholders to obtain necessary information for a defensible decision. Prepare and submit MDRs through the FDA's electronic MDR (eMDR) system when remediation activities identify reportable events. Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, throughout remediation activities. Manage or participate in high-volume documentation reviews as part of large-scale remediation or retrospective review projects. Maintain accurate, thorough, and audit-ready documentation that supports complaint investigations and MDR decisions. Work efficiently within aggressive deadlines and throughput expectations while maintaining high quality and attention to detail. Essential Skills At least 1+ year of experience in complaint handling, MDR evaluation, or similar experience in a regulated industry. Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements. Ability to interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability. Experience managing high-volume documentation reviews or participating in large-scale remediation or retrospective review projects. Strong analytical skills and exceptional attention to detail. Ability to work effectively in a fast-paced environment. Familiarity with FDA Quality System Regulations, including 21 CFR 820 and electronic medical device records. Additional Skills & Qualifications Bachelor's degree in a relevant field is beneficial but not required. 2+ years of MDR reporting or complaint remediation experience in a medical device or pharmaceutical environment is preferred. Experience working in remediation environments with aggressive deadlines and throughput expectations. Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms. Strong documentation skills and comfort working with electronic systems and databases. Ability to collaborate effectively with cross-functional teams including Quality, Regulatory, and Operations. Work Environment Work is performed in an office setting within a structured, compliance-focused environment. The position follows a hybrid schedule, with on-site work on Tuesday, Wednesday, and Thursday, and remote work from home on Monday and Friday. The role involves extensive use of electronic systems such as complaint management platforms and the FDA's eMDR system, and requires sustained focus on detailed documentation and regulatory requirements. The environment is fast-paced, driven by remediation timelines and throughput expectations, while offering the stability of a long-term contract with potential for direct hire based on performance. Job Type & Location This is a Contract position based out of Mundelein, IL. Pay and Benefits The pay range for this position is $30.00 - $32.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Mundelein,IL.

Application Deadline This position is anticipated to close on May 5, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.